Comparing Meter Accuracy

Anyone who has been trying to control his or her diabetes for more than a few days often gets disappointed with checking blood glucose levels. Our disappointment is sometimes not how high those levels go but how erratic our meters and test strips seem to be behaving.

Meter accuracy is a pain — an emotional pain that can be more than the physical pain of lancing. Just which meter systems are accuracy?

That’s probably the question that people newly diagnosed with diabetes ask me the most. And now for the first time we have the beginning of an answer.

In my 15 years of following diabetes developments I haven’t seen a single scientific comparison of the blood glucose meters that we have to work with. Until now.And now we have a study that compares meters from the major brands as well as some minor ones. The study compared 27 blood glucose monitoring systems including systems from the big four on the American market, LifeScan, Roche, Bayer, and Abbott. These are the four companies that seem to have a lock on reimbursement from almost all medical insurance plans.

Strangely, the study appears without fanfare. I only learned about it from an executive of i-SENS, the Korean meter manufacturer that invited me to visit South Korea last month. i-SENS makes blood glucose meters and test strips for many other companies that sell them under their own names, and I don’t know which, if any, of the meter systems that the new study evaluated came from i-SENS.
The study appeared in the February 2010 issue of Diabetes Technology & Therapeutics as “System Accuracy Evaluation of 27 Blood Glucose Monitoring Systems According to DIN EN ISO 15197.” Even better news is that this journal’s publisher, Mary Ann Liebert Inc., is providing complimentary online access to the full-text of three of its publications through the end of November in honor of World Diabetes Day, which was on November 14. In addition to Diabetes Technology & Therapeutics, this includes Metabolic Syndrome and Related Disorders and Childhood Obesity. You can read the full-text of the meter accuracy study at http://www.liebertonline.com/doi/pdfplus/10.1089/dia.2009.0128.
At first glance the study may not appear relevant to Americans, because it evaluates the systems according to European standards. But the fact is that the U.S. Food and Drug Administration has de facto adopted those standards for the U.S.

The European standards are that at least 95 percent of our blood glucose test results have to fall within plus or minus 15 mg/dl of the true result when the level is below 75 mg/dl. The standard allow a little more leeway at higher levels. Our test results have to fall within plus or minus 20 percent when the level is above 75 mg/dl. That’s simply because test results at lower levels are critical — particularly in terms of insulin dose — so these standards make sense.

The good news is that blood glucose systems from three of the four major meter manufacturers fulfilled the European requirements. Five meters from the big four fulfilled the requirements 100 percent. These are Roche’s Accu-Chek Aviva and Accu-Chek Active, Abbott’s FreeStyle Freedom and FreeStyle Lite, and LifeScan’s One Touch Ultra2. Also scoring 100 percent were two meters from a smaller company, Bionime.

In total, 16 of the 27 systems in the study fulfilled Europe’s minimum accuracy requirements. That means, of course, that more than 40 percent of them simply aren’t good enough. Quite a few of these meters are, however, not even sold in the U.S.

We knew, of course, that our meters in general aren’t good enough. And now we know which ones that we can tend to trust.

Anyway, I do encourage you to read the system accuracy evaluation study. At a minimum, please note the tables on “BG Monitoring System Accuracy Results” and “Clarke Error Grid Analysis.” Then, you may want to get a meter to replace the old one that you have been using.

This article is based on an earlier version of my article published by HealthCentral.

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I am a freelance medical writer, advocate, and consultant specializing in diabetes. I was diagnosed with type 2 diabetes in February 1994, I began to write entirely about that condition. My articles and columns have appeared in many of the major diabetes magazines and websites.

The differences of those readings do look like a lot, but in terms of percentage they are acceptable. The differences are acceptable. Whichever the correct number is is not acceptable. Far too high! The rules that the manufacturers have to follow allow a greater degree of range for really high numbers like yours than when the number is low. That’s because smaller differences in numbers, when levels are, say, below 90, could be really troublesome if it was actually below, say, 60. So you may need to see your doctor to adjust your medicine. Of course, you must reduce the amount of sugar and starch that you eat, which is what makes your blood sugar levels so high.

I just got the accu-chek nano (newly diagnosed diabetic) and have been experiencing readings from the same lance that vary enough to be disturbing. For example: reading one 349, second reading 291 just moments ago. I’m trying to find out if I’ve got a defunct reader, bad strips, or doing something wrong. Could you send me the PDF of the study?

Hi David,
I have had over 20% difference with a friend’s tester and mine, exact same brand (roche performa) and it is really worrying when your fasting is 99 or 120 at the same time with 2 identical testers. Is this really acceptable?
Could you please send me the PDF as well
thanks a lot

I would also like a pdf copy of the 27 meters comparison study please…I was only able to download the other study comparing 5 devices at:
“http://online.liebertpub.com/doi/pdfplus/10.1089/dia.2011.0170”

Also, would like your opinion on the Accu-Check Nano & Contour USB meters’ performance and accuracy…Thanks a lot for your help!

Dear David,
The 27 glucometer comparison trial based on ISO15197 has one problem that’s not been highlighted ie as the test results is done based on fasting blood glucose readings, it does not address the problem raised by the non-glucose interference caused by using the reagent GDH-PQQ in the test strips. These problems may not be significant in the US but meters using this GDH-PQQ reagents are still widely available outside the US.
regards,
Peter Ting

I don’t think that the Nano is available for sale in the U.S. At least I have never seen one. I do know that the Accu-Chek Aviva, which is one of the most accurate meters, tests higher than LifeScan meters. I trust the Aviva readings on the basis of my reading and experience with them.

Hi David, I’d love to get a copy of this article, also. We are on a pretty tight budget but having the best info about meters is really important! I’ve requested it from our local library but I don’t know if they’ll be able to get it. Thanks in advance!

About Me

I am a freelance medical writer, advocate, and consultant specializing in diabetes. I was diagnosed with type 2 diabetes in February 1994, I began to write entirely about that condition. My articles and columns have appeared in many of the major diabetes magazines and websites. Read more